Clinical Trials

❘❙❚■ Chapter 11 | Factorial DesignTable 3. Examples of factorial trial notations.Factorial design Example Resulting intervention groups2 × k, Comparison of sequential Treatment 1eg, 2 × 3 three-drug regimens as initialtherapy for HIV-1infection [6] Treatment 2 DDI + D4T ZDV + 3TCNFV NFV + DDI + D4T NFV + ZDV + 3TCEFV EFV + DDI + D4T EFV + ZDV + 3TCNFV + EFV EFV + NFV + DDI + D4T EFV + NFV + ZDV + 3TC2 × 2 × 2 ISIS-4: A randomized factorial OC = Yes: OC = No:trial assessing early OC, OM,and IMS in 58,050 individualsOMOMwith suspected myocardial IMS Yes No IMS Yes Noinfarction [2]Yes OC + OM OC + IMS Yes OM + IMS IMS+ IMSNo OC + OM OC No OM Placebo2 × 2 × 2 A factorial trial of six× 2 × 3 × 2 interventions for theprevention of postoperativenausea and vomiting [10]See belowConsentedn = 5,262Withdrewn = 63Randomlyassignedn = 5,199n = 424n = 181n = 191Ondansetronn = 5,199Dexamethasonen = 5,199Droperidoln = 5,199Maintenancen = 5,199Carrier gasn = 4,594Remifentaniln = 4,827RandomOutcome dataAssignment analyzableOutcome dataincompleteYesn = 2,591Non = 2,608Yesn = 2,617Non = 2,582Yesn = 2,568Non = 2,613Propofoln = 3,455Volatileanestheticn = 1,744NItrogenn = 2,164Nitrous oxiden = 2,150Oxygenn = 280Yesn = 2,403No (fentanyl)n = 2,424n = 15n = 23n = 21n = 17n = 13n = 25n = 28n = 10n = 18n = 19n = 0n = 17n = 21Yesn = 2,576Non = 2,585Yesn = 2,596Non = 2,565Yesn = 2,573Non = 2,588Propofoln = 3,427Volatileanestheticn = 1,734NItrogenn = 2,146Nitrous oxiden = 2,131Oxygenn = 280Yesn = 2,386No (fentanyl)n = 2,403n = 5,161n = 5,161n = 5,161n = 5,161n = 4,277n = 4,789Analysisof fourfactorsn = 5,161Analysisof sixfactorsn = 5,1613TC = lamivudine; D4T = stavudine; DDI = didanosine; EFV = efavirenz; IMS = intravenous magnesium sulfate;NFV = nelfinavir; OC = oral captopril; OM = oral mononitrate; ZDV = zidovudine [2,6,10]. The table below row 3is reproduced with permission from the Massachusetts Medical Society [10].108